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Did You Know?

Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) is a new COVID-19 vaccination that the FDA has approved for Emergency Use Authorization (PHE) for individuals 18 years or older (link).

Why is Matters?

This is the first protein-based COVID-19 vaccine to receive Emergency Use Authorization and CDC endorsement (link) in the United States. This vaccine is to be administered as a series of two doses given three weeks apart. It is not authorized for use as a booster dose.

According to an HHS Press Release (link), “The Novavax COVID-19 vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax COVID-19 vaccine contains SARS-CoV-2 recombinant spike protein, which is also known as an “antigen” of the SARS-CoV-2 virus, in combination with an adjuvant, which enhances the immune system response to the spike protein.

FDA-approved protein-based vaccines have been used widely for decades; examples of more recently approved vaccines that contain a purified protein combined with an adjuvant include vaccines to prevent hepatitis B and shingles. The Novavax COVID-19 vaccine offers an option to individuals who may be allergic to a component in the mRNA vaccines, or who have a personal preference for receiving a vaccine other than an mRNA-based vaccine.”

What Can You Do?

As a health care professional review the CDC’s overview and safety information about this vaccine (link), and become familiar with how to code and bill for this newly vaccine.

Coding and Billing

CMS issued new codes for this vaccine, effective July 13.

• Vaccine code: 91304,
• Administration codes: 0041A and 0042A,

Did You Know?

August is National Immunization Awareness Month (NIAM). According to the CDC (link), NIAM “is an annual observance held in August to highlight the importance of vaccination for people of all ages.”

Why It Matters?

Immunity from childhood vaccines can wear off over time. Maintaining current with your immunizations throughout life helps you combat vaccine preventable diseases. The CDC advises (link) that all adults need:

• COVID-19 vaccine,
• Influenza (flu) vaccine every year, and
• Tetanus and diphtheria (Td) or Tetanus, diphtheria, and pertussis (Tdap) vaccine every ten years.

On a personal note, I received a Tetanus shot on my twenty-first birthday, making it easier to remember to get an updated Tdap shot on my thirty-first, forty-first, and most recently fifty-first birthday.

Forgive me for getting on my soap box for a minute, a vaccination to prevent shingles is also a must for adults. Having watched my mother suffer through the agonizing pain of shingles, I ask the question, why would you suffer through this disease when two doses of Shingrix provides strong protection against shingles and postherpetic neuralgia (PHN)? In fact, the CDC cites that “in adults 50 to 69 years old with healthy immune systems, Shingrix was 97% effective in preventing shingles; in adults 70 years and older, Shingrix was 91% effective (link). This series of two vaccines was my gift to myself when I turned fifty.

One more request is that you consider receiving a pneumonia vaccine. Based on the following CDC stats about Pneumonia in the United States, as a nation, we could do better.

• In 2020, the percent of adults aged eighteen and over who had ever received a pneumococcal vaccination was 25.5%.
• Data from 2018 revealed that 1.5 million emergency department visits had a primary diagnosis of pneumonia.
• Mortality data from 2020 revealed there were 47,601 deaths from pneumonia and deaths per 100,000 population was 14.4.

There are four pneumococcal vaccines licensed for use in the United States by the Food and Drug Administration:

PCV13: Prevnar 13® (pneumococcal conjugate vaccine or PCV13) is a registered trademark by Wyeth LLC and marketed by Pfizer Inc. This vaccine provides protection against infections caused by six more serotypes than PCV7. This vaccine is part of the routine childhood immunization schedule. Additionally, in 2011, it was licensed by the FDA for use in adults 50 years or older. The CDC recommends PCV13 for

• All children younger than 2 years old, and
• People 2 years or older with certain medical conditions.

The CDC advises adults 65 years and older to discuss the need for this vaccine with their health care provider.

PCV 15: Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine)

On July 16, 2021, Merck announced (link) the FDA approval of Vaxneuvance™, a new vaccine for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes.

PCV20: Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine)

On June 8, 2021, Pfizer announced (link) the FDA approval of the Prevnar 20™ vaccine for adults 18 years or older and noted that it is “the first approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S.”

PPSV23: Pneumovax23® (pneumococcal polysaccharide vaccine or PPSV23) is a Merck product. This vaccine was approved by the FDA in 1983 and helps protect against twenty-three types of pneumococcal bacteria. The CDC recommends this vaccine for

• All adults 65 years or older,
• People 2 through 64 years old with certain medical conditions (i.e., diabetes, heart disease or COPD), and
• Adults 19 through 64 years old who smoke cigarettes.

What Can You Do?

As a healthcare provider, work with your patients to identify what vaccinations they have and have not received and utilize available resources on the CDC website for healthcare providers related to vaccinations, for example:

• Immunization Schedules Resources for Health Care Providers: https://www.cdc.gov/vaccines/schedules/hcp/resources.html, and
• Adult Vaccination Information for Healthcare and Public Health Professionals: https://www.cdc.gov/vaccines/hcp/adults/index.html.

As a healthcare consumer:

• Keep your vaccination records up to date (link),
• Use the CDC’s Adult Vaccine Assessment Tool (link) to determine which vaccines are recommended for you, and
• Share all this information with your healthcare provider so you make an informed decision on what immunizations you may need.

CMS recently released the Calendar Year (CY) Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule. In last week’s newsletter (link) we reviewed proposed changes to the Inpatient Only (IPO) List. This week’s focus is on the Ambulatory Surgery Center Covered Procedure List (CPL) and the Hospital Outpatient Prior Authorization Program proposals.

Ambulatory Surgery Center (ASC) Covered Procedure List (CPL)

The CMS evaluates the ASC CPL yearly to determine whether to add or remove specific procedures from the list. Covered surgical procedures performed on or after January 1, 2022, are:

• Procedures specified by the Secretary and published in the Federal Register,
• Separately paid under the OPPS,
• Would not be expected to post a significant safety risk to a Medicare beneficiary when performed in an ASC, and
• Standard medical practice dictates the expectation that the beneficiary would not typically require active medical monitoring and care at midnight following the procedure.

For CY 2023, CMS proposed to add one procedure to the ASC CPL:

• CPT 38531 (Biopsy or excision of lymph node(s); open, inguinofemoral node(s)).

RTMD Data Analysis

I turned to our sister company, RealTime Medicare Data (RTMD) to help estimate the potential impact to hospital outpatients if this procedure can also occur in an ASC setting. The claims data represents Medicare Fee-for-Service paid claims in calendar year 2021 for CPT 38531 for all states in the RTMD footprint. Currently, this includes all states except Kentucky and Ohio.

• Overall Claims Volume: 4,606
• CPT Payment: $13,088,298.18
• Top 5 States
• California had 411 claims with a payment of $1,468,801.23,
• Florida had 338 claims with a payment of $939,648.34,
• Texas had 253 claims with a payment of $705,682.74,
• Pennsylvania had 245 claims with a payment of $721,419.95, and
• New York has 229 claims with a payment of $651,816.93.

CMS ends this section of the proposed rule by noting they “believe that any additions to the CPL should be added in a carefully calibrated fashion to ensure that the procedure is safe to be performed in the ASC setting for a typical Medicare beneficiary. We expect to continue to gradually expand the ASC CPL, as medical practice and technology continue to evolve and advance in future years. We encourage stakeholders to submit procedure recommendations to be added to the ASC CPL, particularly if there is evidence that these procedures meet our criteria and can be safely performed on the typical Medicare beneficiary in the ASC setting.”

Hospital Outpatient Prior Authorization Program

The Prior Authorization for Certain Hospital Outpatient Department (OPD) Services initiative became effective on July 1,2020 and made a prior authorization request (PAR) a condition of payment for specific service categories. Service categories effective July 1, 2020, included:

• Blepharoplasty,
• Botulinum toxin injections,
• Panniculectomy,
• Rhinoplasty, and
• Vein ablation.

Effective July 1, 2021, CMS added cervical fusion with disc removal and implanted neurostimulators as new service categories.

You can learn more about this initiative on the CMS Hospital OPD Services initiative webpage (link).

CMS has proposed to add Facet Joint Interventions as a new service category and would include facet joint injections, medial branch blocks and facet joint nerve destruction CPT codes. This list of applicable CPT codes is in Table 79 of the proposed rule. If finalized, this would be effective for dates of services on or after March 1, 2023.

CMS Data Analysis

CMS performed data analysis of CPT codes 64490-64495 (Facet Injections and Medical Branch Blocks) and CPT Codes 64633-64636 (Nerve destruction services). Analysis revealed facet joint intervention claims volume increased by 47 percent between 2012 and 2021. This reflected a 4 percent average annual increase which is higher than the 0.6 percent annual increase for all outpatient department services.

Contractor Scrutiny

As part of the discussion for adding facet joint interventions to this initiative, CMS includes discussion of prior audits performed by the OIG and Department of Justice.

• OIG Report Medicare Improperly Paid Physicians for More Than Five Spinal Facet-Joint Injections Sessions During a Rolling 12-Month Period (A-09-20-03003) published October 2020 (link): The OIG found that MACs in the 11 jurisdictions with a coverage limitations made improper payments of $748,555.
• OIG Report Medicare Improperly Paid Physicians for Spinal Facet-Joint Denervation Sessions (A-09-21-03002) published December 2021 (link): The OIG found that Medicare improperly paid physicians $9.5 million.

In addition to past reports, there are two active OIG Work Plan items related to facet joint procedures.

• In the Department of Justice case reference in the proposed rule, the DOJ reported on a $250 million health care fraud scheme where “to obtain prescriptions, the evidence showed that the patients had to submit to expensive, unnecessary and sometimes painful back injections, known as facet joint injections.”

CMS notes, “both our data analysis and research show that the increases in volume for these procedures are unnecessary, and further program integrity action is warranted.”

RTMD Data Analysis

I once again turned to RTMD to help estimate the potential impact of adding Facet Joint Interventions to the prior authorization initiative. Keep in mind that data volume includes all procedures and there may be claims that could include multiple facet procedures in the same encounter.

Facet Injections and Medical Branch Blocks (CPT 64490-64495)

• Overall Claims Volume: 391,410
• CPT Payment: $141,144,372.81
• Top 5 States
• Texas had 40,472 claims with a payment of $13,102,475.35
• California had 24,109 claims with a payment of $11,433,125.41,
• Massachusetts had 23,738 claims with a payment of $9,892,874.58,
• New York had 18,901 claims with a payment of $6,922,608.02, and
• Pennsylvania had 18,624 claims with a payment of $6,764,696.64.

Facet Joint Nerve Destruction (CPT codes 64633-64636)

• Overall Claims Volume: 185,564
• Sum CPT Paid: $124,386,756.18
• Top 5 States
• Texas had 19,051 claims with a payment of $12,335,211.47,
• California had 11,620 claims with a payment of $10,144,086.72,
• Florida had 8,641 claims with a payment of $4,970,708.01,
• Illinois had 8,023 claims with a payment of $4,782,664.98, and
• Pennsylvania had 7,711 claims with a payment of $5,205,371.13.

CMS is accepting comments on the proposed rule through September 13, 2022.

Resource

CMS CY 2023 Proposed Rule webpage: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Annual-Policy-Files

Medicare MLN Articles & Transmittals

Change to the Laboratory National Coverage Determination (NCD) Edit Software for October 2022

• MLN Release Date: June 24, 2022
• What You Need to Know: CMS advises you to make sure your billing staff know about changes to the Laboratory NCD Edit Module for October 2022 and how to access the NCD spreadsheet that lists relevant changes.
• MLN MM12803: (link)

One-Time Notification: New Edit for PPS Outpatient and Inpatient Bill Types Receiving Outlier Payment When Device Credit is Reported

• Transmittal Release Date: July 7, 2022
• What You Need to Know: A new edit is being implemented to provide MACs with a way to review the charges and device reduction amount submitted on claims for fully or partially credited devices. Effective January 1, 2023, CMS will suspend outpatient and inpatient prospective payment claims getting an outlier payment when a device credit is reported. This will allow the MACs to review the charges and device reduction amounts for fully and partially credited devices.
• Transmittal 11488 (Change Request 12769): (link)

Coverage Updates

July 6, 2022: Cochlear Implantation Proposed Decision Memo (CAG-00107R)

CMS released a Proposed Decision Memo regarding the National Coverage Determination for Cochlear Implantation (50.3) (link). Among other things, CMS is proposing to expand coverage by broadening the patient criteria and removing the requirement that for individuals with hearing test scores of > 40 % and ≤ 60 %. The public comment period ends August 5, 2022.

July 8, 2022: Home Use of Oxygen Final Decision Memo

Per the Final Decision Memo (link), “Effective July 8, 2022, the MAC may determine reasonable and necessary coverage of oxygen therapy and oxygen equipment in the home for patients who are not described in section B or precluded by section C of this NCD. Initial coverage for patients with other conditions may be limited to the shorter of 90 days or the number of days included in the practitioner prescription at MAC discretion. Oxygen coverage may be renewed if deemed medically necessary by the MAC.”

Compliance Updates

Implanted Spinal Neurostimulators: Document Medical Records

In a recent report, the OIG found that Medicare improperly paid claims for implanted spinal neurostimulators when providers did not provide sufficient documentation supporting medical necessity. You will find a link to the OIG report and helpful resources in the Thursday July 21, 2022, edition of their MLN Connects e-newsletter ( https://www.cms.gov/outreach-and-educationoutreachffsprovpartprogprovider-partnership-email-archive/2022-07-21-mlnc">link).

COVID-19 Updates

Coding Long COVID

CMS offered the following advice regarding coding Long COVID in the Thursday July 7, 2022, edition of MLN Connects (link):

• For a post COVID-19 condition, unspecified, like Long COVID, use code DX U09.9. Add other codes for conditions related to the COVID-19 infection, like R50.9 for fever.
• For a current COVID-19 infection, use code DX U07.1. Do not use code DX U09.9.
• For a current COVID-19 infection and conditions from a previous COVID-19 infection, use code U09.9 with code DX U07.1. Add other codes for conditions related to the COVID-19 infection, like R06.02 for shortness of breath.
• For more information, see pages 30-31 of ICD-10-CM Official Guidelines for Coding and Reporting: Fiscal Year 2022 (PDF).

July 13, 2022: CDC Releases Resistant Infections Special Report

The CDC released a report (link) detailing the negative effect of the COVID-19 pandemic on recent years of progress in the United States combating antimicrobial resistance (AR). In a related announcement, the CDC noted the report “concludes that the threat of antimicrobial-resistant infections is not only still present but has gotten worse – with resistant hospital-onset infections and deaths both increasing at least 15% during the first year of the pandemic.”

July 15, 2022: COVID-19 Public Health Emergency Renewed

CMS waited until late Friday, July 15th to post an extension of the COVID-19 public health emergency (PHE) (link). This extends the PHE for ninety days.

Other Updates

July 7, 2022: Special Edition MLN Connects – Physician Fee Schedule Proposed Rule release

CCMS announced the release of the CY 2023 Physician Fee Schedule Proposed Rule in a special edition of their MLN Connects e-newsletter (link). You will find links to related fact sheets and the proposed rule in the newsletter. Comments are due to CMS by September 7, 2022.

July 7, 2022: Appropriate Use Criteria (AUC) Penalty Phase Delayed Again

CMS as posted the following notice on the AUC Program webpage (link), “The payment penalty phase will not begin January 1, 2023 even if the PHE for COVID-19 ends in 2022. Until further notice, the educational and operations testing period will continue. CMS is unable to forecast when the payment penalty phase will begin.”

July 16, 2022: New Nationwide 988 Crisis Hotline

HHS announced in a July 15th Press Release (link), the transition from the 10-digit National Suicide Prevention Lifeline to 988 “an easy-to-remember three-digit number for 24/7 crisis care…The 988 Suicide & Crisis Lifeline is a network of more than 200 state and local call centers supported by HHS through the Substance Abuse and Mental Health Services Administration (SAMHSA).”

True to form, the CMS announced the release of the Calendar Year (CY) 2023 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule late last Friday July 16th. This week we review the proposed changes to the Inpatient Only (IPO) list.

CMS once again reminds providers in this proposed rule that “Designation of a service as inpatient only does not preclude the service from being furnished in a hospital outpatient setting but means that Medicare will not make payment for the service if it is furnished to a Medicare beneficiary in the hospital outpatient setting (65 FR 18443). Conversely, the absence of a procedure from the list should not be interpreted as identifying that procedure as appropriately performed only in the hospital outpatient setting (70 FR 68696).”

Before reviewing proposals, here is a quick look back at the “flip flopping” of CMS over the past two calendar years. In CY 2021, CMS removed 298 musculoskeletal-related services from the IPO List and finalized the elimination of the list over three years. In CY 2022, CMS did an about face and finalized the following changes:

• The IPO list will not be eliminated over three years,
• Most procedures removed from the IPO list in CY 2021 were added back to the list for CY 2022, and
• The five longstanding criteria for determining whether a service or procedure should be removed from the IPO list was codified in regulation text.

Calendar Year 2023 Proposed Procedures for Removal from the IPO List

CMS is proposing to remove ten procedures from the IPO list.

CPT code 16036 (Escharotomy; each additional incision (list separately in addition to code for primary procedure)). This code is an add-on code typically billed with primary procedure CPT 10635 (escharotomy; initial incision) which was removed from the IPO list in CY 2007.

CPT code 22632 (Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; each additional interspace (list separately in addition to code for primary procedure)). This code is an add-on code typically billed with primary procedure CPT 22630 (Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar), which was removed from the IPO list in CY 2021. Note, this code was removed from the IPO list in CY 2021 and replaced back on the list for CY 2022.

The remaining eight procedures proposed for removal from the IPO list are all maxillofacial procedures removed from the IPO list in CY 2021 and replaced back on the list for CY 2022:

• CPT code 21141 (Reconstruction midface, lefort I; single piece, segment movement in any direction (e.g., for long face syndrome), without bone graft).
• CPT code 21142 (Reconstruction midface, lefort I; 2 pieces, segment movement in any direction, without bone graft).
• CPT code 21143 (Reconstruction midface, lefort I; 3 or more pieces, segment movement in any direction, without bone graft).
• CPT code 21194 (Reconstruction of mandibular rami, horizontal, vertical, C, or L osteotomy; with bone graft (includes obtaining graft)).
• CPT code 21196 (Reconstruction of mandibular rami and/or body, sagittal split; with internal rigid fixation).
• CPT code 21347 (Open treatment of nasomaxillary complex fracture (lefort II type); requiring multiple open approaches).
• CPT code 21366 (Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with bone grafting (includes obtaining graft)); and
• CPT code 21422 (Open treatment of palatal or maxillary fracture (lefort I type);).

Calendar Year 2023 Proposed Additions to the IPO List

CMS has proposed the addition of eight newly created codes by the AMA CPT Editorial Panel to the IPO list for CY 2023:

• 157X1 (Implantation of absorbable mesh or other prosthesis for delayed closure of defect(s) (i.e., external genitalia, perineum, abdominal wall) due to soft tissue infection or trauma,
• 228XX (Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression); second interspace, lumbar (List separately in addition to code for primary procedure),
• 49X06 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), initial, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, incarcerated or strangulated),
• 49X10 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); 3 cm to 10 cm, incarcerated or strangulated),
• 49X11 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, reducible,
• 49X12 (Repair of anterior abdominal hernia(s) (i.e., epigastric, incisional, ventral, umbilical, spigelian), any approach (i.e., open, laparoscopic, robotic), recurrent, including placement of mesh or other prosthesis when performed, total length of defect(s); greater than 10 cm, Incarcerated or strangulated,
• 49X13, (Repair of parastomal hernia, any approach (i.e., open, laparoscopic, robotic), initial or recurrent, including placement of mesh or other prosthesis, when performed; reducible), and
• 49X14 (Repair of parastomal hernia, any approach (i.e., open, laparoscopic, robotic), initial or recurrent, including placement of mesh or other prosthesis, when performed; incarcerated or strangulated).

All proposed changes to the IPO list, including the CPT code, longer descriptor, proposed action (deletion or addition), proposed status indicator and for proposed deletions the proposed APC assignment are listed in Table 46 of the proposed rule.

CMS is accepting comments on the proposed rule through September 13, 2022.

Resources

CY 2023 OPPS Proposed Rule

• CMS Press Release: https://www.cms.gov/newsroom/press-releases/cms-proposes-rule-advance-health-equity-improve-access-care-and-promote-competition-and-transparency
• CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center
• Proposed Rule: https://www.federalregister.gov/public-inspection/2022-15372/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment

Did You Know?

Last month, MMP published an article highlighting the new RAC issue 0210: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea (link). Since then, all the Recovery Auditor regions have added this new complex issue to their list of approved issues.

What Can You Do?

If your hospital is providing this service, now is the time to review a few medical records against your MACs coverage requirements to ensure you are following the provisions of the policy and billing and coding article. The RAC issue includes a listing of each of the MACs LCDs and Billing and Coding Articles.

For those in the Palmetto MAC jurisdictions J and M, Palmetto has published an article (link) about HNS that includes links to a hypoglossal nerve stimulator checklist and their LCD.

You can also visit Inspire Medical System, Inc’s Inspire Sleep Apnea Innovations webpage (link). Information available for patients includes:

• Cost and Eligibility,
• Patient Stories,
• FAQ,
• Free Informational Events, and
• A four-question assessment to see if you qualify for this system.

Information available for Healthcare Professionals (link) includes:

• Indications/Contraindications,
• A Patient Experience Report,
• Reimbursement information (Hospital, Physician and Sleep Services Billing Guides),
• Training and Education Tools, and
• Digital Health Documents.

MMP’s Protection Assessment Report (P.A.R.) combines current Medicare Fee-for-Service review targets (i.e., MAC, RAC, OIG) with hospital specific paid claims data made possible through a collaboration with RealTime Medicare Data (RTMD). In general, this monthly article spotlights current review activities. However, this month in keeping with the Hallmark Channel’s Christmas in July celebration, MMP would like to recognize the OIG’s Health Care Fraud and Abuse Control Program’s 25th year of operation and celebrate Medicare’s 57th birthday!

Health Care Fraud and Abuse Control Program Celebrates its 25th Year of Operation

On July 5, 2022, The Office of Inspector General (OIG) released the Department of Health and Human Services and The Department of Justice’s Health Care Fraud and Abuse Control (HCFAC) Program Report for Fiscal Year 2021 (link). The OIG’s notice of this report’s release indicated the HCFAC “Program is celebrating its 25th year of operation and continued success in identifying and prosecuting the most egregious instances of health care fraud, preventing future fraud and abuse, and protecting program beneficiaries.”

HCFAC Report OIG and CMS Highlights

• In its 25th year of operation, the Secretary and the Attorney General certified $321.6 million in mandatory funding necessary for the Program. In addition, Congress appropriate $807.0 million in discretionary fundings.
• The OIG was allocated just over $300 million, and the Centers for Medicare and Medicaid Services was allocated almost $600 million.
• During FY 2021, the Federal Government won or negotiated more than $5.0 billion in healthcare fraud judgments and settlements.
• The HCFAC Program’s return on investment (ROI) over the last three years (2019-2021) is $4.00 returned for every $1.00 expended. Note, “this ROI relies on actual recoveries and collections, and does not represent the effect of preventing future fraudulent payments.”

OIG Efforts

• The OIG is the leading oversight agency specializing in health care fraud and “employs a multi-disciplinary approach and uses data-driven decision-making to produce outcome-focused results.”
• The OIG’s priority outcome areas fall into two broad categories:
• Minimize risk to beneficiaries, and
• Safeguard programs from improper payments and fraud.
• In FY 2021, the OIG issued 162 audit reports and 46 evaluations, resulting in 506 new recommendations issued to HHS operating divisions, HHS grantees and other entities. Out of 506 recommendations made in FY 2021, 432 were implemented in FY 2021.

CMS Efforts

• “CMS defines program integrity very simply, “pay it right.” Program integrity focuses on paying the right amount, to legitimate providers and suppliers, for covered, reasonable and necessary services provided to eligible beneficiaries, while concurrently taking aggressive actions to eliminate fraud, waste, and abuse. Federal health programs are quickly evolving; therefore, CMS’s program integrity strategy must keep pace to address emerging challenges.”
• Unified Program Integrity Contractors (UPICs) medical reviews “are uniquely focused on fraud detection and investigation. Currently, UPICs are carrying out program integrity activities in all five geographic jurisdictions: Midwest, Northeast, West, Southeast, and Southwest.
• CMS used the Medical Review Accuracy Contractor (MRAC) to conduct medical review of claim determinations made by Medicare Medical Review Contractors including MACs, UPICs, the Supplemental Medicare Review Contractor (SMRC) and in 2021 the RACs while procurement for the RAC Validation Contractor (RVC) was underway.

Happy 57th Birthday Medicare!

On July 30, 1965, President Lyndon B. Johnson signed into law the bill that led to the Medicare and Medicaid. President and First Lady Truman were the first Medicare Beneficiaries.

Did You Know?

In the CMS 2021 Edition of Medicare Beneficiaries at a Glance (link), in 2019:

• 61.5 million people were enrolled in Medicare,
• 3.8 million of these people were new enrollees,
• 49% of enrollees were between the ages of 65 and 74,
• 63% of enrollees were enrolled in the traditional Medicare Fee-for-Service plan, and
• The top five chronic conditions were high blood pressure, high cholesterol, arthritis, diabetes, and heart disease.

In honor of Medicare’s birthday and in keeping with our monthly focus on Medicare Contractors, following is a list of useful resources provided by the CMS for our readers:

• Review Contractor Interactive Map: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Review-Contractor-Directory-Interactive-Map
• Medicare Fee for Service Compliance Programs webpage: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Overview
• CMS’ Medicare Learning Network (MLN) webpage: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNGenInfo
• Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx
• MLN Fact Sheet: Collaborative Patient Care is a Provider Partnership:
• Medicare Internet Only Manuals:

Did you know?

Did you know that a new code has been created to identify unspecified Depression, NOS, effective October 1, 2021?

Previously in ICD--10, when a provider documented Depression, NOS, it was assigned to Major Depression, Single Episode, code (F32.9); however, only 10% out of 30% of patients that report symptoms of Depression, have Major Depression. Therefore, a new code has been created to capture Depression NOS.

• Depression, Unspecified (F32.A) • Depression NOS (F32.A) • Depressive Disorder NOS (F32.A)

Major Depression, Single Episode, Unspecified and Major Depression NOS is still assigned to code (F32.9).

Why it matters.

You may not be capturing the most accurate severity of illness of the patient.

What can I do?

Read Coding Clinic for ICD-10-CM/PCS, Fourth Quarter 2021: Page 9

In the Thursday June 30 2022, edition of MLN Connects (link), CMS included the following information about Pfizer-BioNTech vaccines for children as young as six months and new CPT vaccine codes:

“On June 17, 2022, the FDA amended the Pfizer-BioNTech COVID-19 vaccine emergency use authorization (PDF) (link) to authorize use for all patients 6 months – 4 years old. Get important vial and dosing information. (link) CMS issued new CPT codes effective June 17, 2022:

Code 91308 for vaccine product:

• Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation, for intramuscular use
• Short descriptor: SARSCOV2 VAC 3 MCG TRS-SUCR

Code 0081A for vaccine administration, first dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; first dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 1

Code: 0082A for vaccine administration, second dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; second dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 2

Code 0083A for vaccine administration, third dose:

• Long descriptor: Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (coronavirus disease [COVID-19]) vaccine, mRNALNP, spike protein, preservative free, 3 mcg/0.2 mL dosage, diluent reconstituted, tris-sucrose formulation; third dose
• Short descriptor: ADM SARSCV2 3MCG TRS-SUCR 3

Visit the COVID-19 Vaccine Provider Toolkit (link) for more information, and get the most current list of billing codes, payment allowances, and effective dates. (link) Note: you may need to refresh your browser if you recently visited this webpage.”

On June 30th, a proposed rule was released titled, Conditions of Participation for Rural Emergency Hospitals and Critical Access Hospital COP Updates (CMS-3419-P). A related CMS Fact Sheet (link) notes that “Rural Emergency Hospitals (REHs) are a new provider type established by the Consolidated Appropriations Act of 2021 to address the growing concern over closures of rural hospitals. The REH designation provides an opportunity for Critical Access Hospitals (CAHs) and certain rural hospitals to avert potential closure and continue to provide essential services for the communities they serve.”

The proposed CoPs for REH providers were modeled closely after the CoPs for Critical Access Hospitals (CAHs) and in some instances CoPs for hospitals and ambulatory surgery centers (ASCs).

Per CMS, discussion of Medicare payment; quality reporting and enrollment policies are to be included in the calendar year (CY) 2023 Outpatient Prospective Payment System-Ambulatory Surgery Center (OPPS/ASC) proposed rule. The REH CoPs final rule is expected to be included in the CY 2023 OPPS/ASC final rule.

Definition for a Rural Emergency Hospital

REHs are defined as being “A facility that is enrolled in the Medicare program as an REH; does not provide any acute care inpatient services (other than post-REH, that is after discharge from an REH, or post-hospital extended care services furnished in a distinct part unit licensed as a skilled nursing facility (SNF)); has a transfer agreement in effect with a level I or level II trauma center; meets certain licensure requirements; meets requirements of a staffed emergency department; meets staff training and certification requirements established by the Secretary of the Department of Health and Human Services (the Secretary); and meets certain CoPs applicable to hospital emergency departments and CAHs with respect to emergency services.”

Fast Facts about REHs

• To become an REH, a facility must have been a CAH or have been classified as a rural hospital with not more than 50 beds as of the date the Consolidated Appropriations Act (CAA) of 2021 was signed into law on December 27, 2020.
• REHs are required to provide emergency department services and observation care. An REH can elect to add additional outpatient medical and health services.
• An REH must have a staffed Emergency Department 24 hours a day, 7 days a week.
• An REH must have a physician, nurse practitioner, clinical nurse specialist, or physician assistant available to furnish rural emergency hospital services in the facility 24 hours a day.
• An REH can act as an originating site for telehealth services furnished on or after January 1, 2023.

REH Payment

REH providers will begin receiving payment for services furnished on or after January 1, 2023. Like other providers participating in Medicare, REHs must enter into a provider agreement with CMS. REHs will receive Medicare payment that is:

• Equal to the amount of payment that would otherwise apply under the Medicare Hospital OPPS for covered outpatient department services increased by 5 percent.
• In addition, an additional monthly facility payment to an REH. The details of the payment policies for REHs will be developed in separate notice and comment rulemaking.
• The beneficiary co-payments for these services will be calculated the same way as under the OPPS for the service, excluding the 5 percent payment increase.

REHs Relationship with Hospitals

CMS notes that “hospital admissions and transfers account for roughly 20 percent of all patient dispositions from the emergency department across the U.S. As a result, we can expect that REHs will transfer at least 20 percent of their patients so we agree with commenters and are therefore proposing to require that REHs have established relationships with hospitals that have the resources and capacity available to deliver care that is beyond the scope of care delivered at the REH.”

Outpatient Surgical Procedures in an REH

CMS acknowledges there will be a need for outpatient surgical services in communities where CAHs convert to an REH. They have proposed “at § 485.524(d) to set forth standards for an REH performing outpatient surgical services that are consistent with the CAH requirements for surgical services at § 485.639. These include proposed standards for ensuring that the services are conducted in a safe manner by qualified practitioners with specific protocols for administering anesthesia.” They expect “REHs, like ASCs, to provide surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission.”

Condition of Participation: Discharge Planning

The proposed Discharge Planning CoPs for REHs are closely aligned with the requirements for hospitals and CAHs.

Distinct Part SNF Unit

Per CMS, “According to a policy brief published by RUPRI Center for Rural Health Policy Analysis, there were 472 nursing home closures between 2008 and 2018 in nonmetropolitan counties in the U.S. The policy brief noted that 10.1 percent of the country’s nonmetropolitan counties had no nursing homes. Given the closures of rural nursing homes and the lack of nursing homes in rural communities, residents living in rural areas may not have adequate access to SNF services. The provision of these services in distinct part units of REHs may help address this access issue.”

A study by the consulting firm CLA’s study (“A Path Forward: CLA’s Simulations on Rural Emergency Hospital Designation”), estimates between 11 and 600 CAHs would benefit from conversion to REH status.

Critical Access Hospitals

This proposed rule also includes proposed updates to the CoPs for CAHs by proposing to:

• Add a definition of primary roads to the location and distance requirements,
• Establish a patient’s rights CoP, and
• Allow for a unified and integrated systems for infection control and prevention and antibiotic stewardship program, medical staff, and quality assessment and performance improvement program (if the CAH is part of a health system containing more than one hospital or CAH).

I encourage you to read the proposed rule and submit comments. One important issue CMS is seeking input on is whether REHs should be permitted to provide low-risk labor and delivery, and whether they should require an REH also provide outpatient surgical services in the event surgical labor and delivery intervention is necessary. CMS is accepting comments through August 29, 2022.

Resource

Proposed Rule - Conditions of Participation for Rural Emergency Hospitals and Critical Access Hospital COP Updates (CMS-3419-P): (link)